FDA Approves In-Vitro Assay to Identify B-Cell Lymphomas, Plasma Cell Neoplasms

A new, highly sensitive in situ hybridization (ISH) test to help clearly identify B-cell lymphomas and plasma cell neoplasms in patients has received 510(k) clearance from the FDA. The test is under development by Roche as the Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail assay. The company announced the FDA clearance in a press release.

This assay is a single-slide, in vitro diagnostic test, which uses ISH to detect expression of kappa and lambda immunoglobulin light chains in formalin-fixed, paraffin-embedded human hematolymphoid specimens. It helps clinicians distinguish more than 60 subtypes of mature B-cell lymphomas and plasma cell neoplasms from normal immune system responses in patients.

“Accurately differentiating lymphoma from an infection is critical in ensuring accurate and timely diagnosis, especially as the symptoms can appear similar,” remarked Jill German, head of the pathology lab at Roche Diagnostics.

The assay had already received CE Mark approval in June 2024, and it is now the first test of its type to receive FDA approval.

“With this new test, clinicians can have confidence in their diagnosis, while the test reduces the need for multiple samples and time consuming follow up tests, giving patients certainty sooner, and enabling faster access to the right treatment,” German elaborated.

The Ventana Kappa and Lambda Dual ISH mRNA Probe Cocktail assay is currently indicated for use when findings from lymph node or bone marrow biopsy are inconclusive. As clinicians use this test in making a diagnosis, its results should be considered alongside patient clinical history and findings from other tests.

Reference

Roche receives FDA clearance for new, highly-sensitive test to aid clinicians in diagnosing B-cell lymphoma. Press release. PR Newswire. January 13, 2025. Accessed January 29, 2025.